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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCLARIS(TM) REWETTING DROPS
Classification Nameaccessories, soft lens products
Generic Namelens rewetting solution
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP900047
Supplement NumberS005
Date Received03/01/1996
Decision Date06/20/1996
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to 1)duplicate wet-n-soak rewetting drops under the trade name claris rewetting drops to be used with claris cleaning and soaking solution (allergan's trade name for destat 4 cleaning, disinfecting, storage solution (p870023)) and 2)add the following to the directions section for claris rewetting drops: before wearing lenses: place 1 or 2 drops of claris rewetting drops on each side of each lens before application.
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